drugset / Trial / NCT00491920
High Dosage Vitamin D and Osteoporosis
Phase 4
Completed
297 enrolled
University Hospital of North Norway
Norske Kvinners Sanitetsforening Troms · collab
RandomizedSingle-groupQuadruple-blindTreatment
Summary
Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women with T-score \<= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week, while the other half will have placebo. The study period is one year.
Timeline
- Start
- 2007-02
- Primary completion
- 2010-02
- Completion
- 2010-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 400 iu | — |
| Subject | Cholecalciferol | Other / unclassified | 20000 iu | — |
| Background | Calcium carbonate | Other / unclassified | 500 mg | — |